Regulatory Roundup for Week of November 5, 2012

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FDA pushes back goals due to Hurricane Sandy and EMA announces changes to variation regulations.

FDA has pushed back goals in relation to the Prescription Drug User Fee Act, the Biosimilar User Fee Act, and Medical Device User Fee Act as a result of the closing of agency offices during Hurricane Sandy. FDA says it will assess the goals that were due Oct. 31, 2012, and extend them as needed. The extensions will be no more than the number of business days the agency was closed. FDA said in a press release that it does not anticipate the need to extend goals for all applications under review and it anticipates that many applications will not require an extension. Certain applications sent that would have been received during the agency’s closure may “present issues regarding calculation of applicable review or regulatory clocks.” FDA asks that sponsors contact the review division or office responsible regarding submissions filed on Oct. 29 or 30, 2012.

The European Medicines Agency (EMA) has released meeting highlights from the Pharmacovigilance Risk Assessment Committee, held Oct. 29–31, 2012.


EMA has announced changes to Variation Regulations. The amendments affect the provisions governing centrally authorized medicines and will go into effect Nov. 2, 2012.